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RecruitingInterventionalPhase 4

Cleansing Options in Outpatient Setting to Improve Tolerance (COOP SIT) Trial

NCT ID: NCT07215000Sponsor: Morehouse School of MedicineLast updated: 2025-10-09

Summary

The purpose of this research is to compare patient preferences for two bowel preparation options: low-volume tablets (Suflave/Sutab) versus the standard colon preparation using Golytely (polyethylene glycol). The study aims to enroll approximately 300 patients, who will be randomly assigned to one of the two preparation methods in a 2:1 ratio prior to their scheduled colonoscopy appointments. Surveys will be conducted both before and after the procedures. This project will be conducted over a 12-month period and seeks to compare patient experience of both preparation methods in an outpatient setting. The study will evaluate the rate of preparation completion, patient satisfaction, tolerance of the solutions, and the endoscopic adequacy of each method. Eligible participants are patients aged 18 or older with upcoming colonoscopy appointments who can provide informed consent in English or Spanish. There is no health risks associated with this study, as both bowel preparation methods are FDA-approved and commonly used in clinical practice.

Arms & interventions

  • DrugGolytely

    large volume liquid prep.

  • DrugSulfave

    SUFLAVE is a split-dose (2-day) regimen. A total of 2 bottles are required for complete preparation for colonoscopy. You will take 2 bottles of liquid in two separate doses. One dose of SUFLAVE is equal to one bottle plus one flavor enhancing packet.

  • DrugSutab

    SUTAB comes in a kit that contains two medication bottles and a cup for water. Each bottle contains 12 tablets (pills). You'll take 12 pills (one bottle) with water from the cup the night before your exam. Later that evening, drink two more cups of water. Fill the cup to the line each time. Then, six hours before your exam, repeat all three of those steps.

Outcome measures

Primary

  • Patient Experience

    Evaluate the patient experience of the two new colon prep options (low volume and tablets) versus conventional bowel prep in an out-patient setting.

    Time frame: Until the end of the study

  • Edoscopic Adequacy

    Assess endoscopic adequacy of the three bowel cleansing solutions

    Time frame: Until the end of the study

Secondary

  • Rate of Completion

    Time frame: Until the end of the study

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: Yes
Inclusion Criteria: * Adults over age of 18 years undergoing outpatient colonoscopy for various indications, ability to consent in English or Spanish. Patients will still be allowed to join if there is a history of colorectal cancer or previous surgery Exclusion Criteria: * Patient is less than 18 years of age, any pregnant or nursing women, unable to consent, or patient is incarcerated.

Study locations (1)

Morehouse School of Medicine

Atlanta, Georgia, 30310

Recruiting
Jesus Luevano, M.D. · Contact
404-971-9018jluevanojr@msm.edu
Julia Liu, M.D. · Contact
404-756-1389jjliu@msm.edu
Jesus Luevano Jr., M.D. · Principal Investigator
Julia Liu, M.D. · Sub Investigator

References

  • Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.(PubMed)
  • Appannagari A, Mangla S, Liao C, Reddy KG, Kupfer SS. Risk factors for inadequate colonoscopy bowel preparations in African Americans and whites at an urban medical center. South Med J. 2014 Apr;107(4):220-4. doi: 10.1097/SMJ.0000000000000087.(PubMed)
  • Pullens HJ, Siersema PD. Quality indicators for colonoscopy: Current insights and caveats. World J Gastrointest Endosc. 2014 Dec 16;6(12):571-83. doi: 10.4253/wjge.v6.i12.571.(PubMed)
  • Hernandez PV, Horsley-Silva JL, Snyder DL, Baffy N, Atia M, Koepke L, Buras MR, Lim ES, Ruff K, Umar SB, Islam S, Ramirez FC. Effect of bowel preparation volume in inpatient colonoscopy. Results of a prospective, randomized, comparative pilot study. BMC Gastroenterol. 2020 Jul 13;20(1):227. doi: 10.1186/s12876-020-01373-1.(PubMed)
  • Ahmad A, Marshall S, Bassett P, Thiruvilangam K, Dhillon A, Saunders BP. Evaluation of bowel preparation regimens for colonoscopy including a novel low volume regimen (Plenvu): CLEANSE study. BMJ Open Gastroenterol. 2023 Mar;10(1):e001070. doi: 10.1136/bmjgast-2022-001070.(PubMed)
  • Vemulapalli KC, Lahr RE, Rex DK. 2021 Patient Perceptions Regarding Colonoscopy Experience. J Clin Gastroenterol. 2023 Apr 1;57(4):400-403. doi: 10.1097/MCG.0000000000001689.(PubMed)
  • Chien C, Morimoto LM, Tom J, Li CI. Differences in colorectal carcinoma stage and survival by race and ethnicity. Cancer. 2005 Aug 1;104(3):629-39. doi: 10.1002/cncr.21204.(PubMed)
  • Primm KM, Malabay AJ, Curry T, Chang S. Who, where, when: Colorectal cancer disparities by race and ethnicity, subsite, and stage. Cancer Med. 2023 Jul;12(13):14767-14780. doi: 10.1002/cam4.6105. Epub 2023 May 22.(PubMed)
  • Ollberding NJ, Nomura AM, Wilkens LR, Henderson BE, Kolonel LN. Racial/ethnic differences in colorectal cancer risk: the multiethnic cohort study. Int J Cancer. 2011 Oct 15;129(8):1899-906. doi: 10.1002/ijc.25822. Epub 2011 Mar 25.(PubMed)
  • Holowatyj AN, Ruterbusch JJ, Rozek LS, Cote ML, Stoffel EM. Racial/Ethnic Disparities in Survival Among Patients With Young-Onset Colorectal Cancer. J Clin Oncol. 2016 Jun 20;34(18):2148-56. doi: 10.1200/JCO.2015.65.0994. Epub 2016 May 2.(PubMed)
  • Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763.(PubMed)
Cleansing Options in Out-Patient Setting to Improve Tolerance (COOP SIT) Trial | Cancerify